(72 days)
Not Found
No
The device description focuses on mechanical components (screws, plates, instruments) and materials, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as "stabilizing and fixating bone grafts, bone filling material and/or barrier membranes" in the oral cavity. Its components (screws, plates) are used for mechanical support and stability, not to treat or cure a disease or condition. This falls under structural support rather than therapeutic action.
No
The device is used for stabilizing and fixating bone grafts and materials in the oral cavity, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly details physical components made of titanium alloy and pure titanium, including bone screws, bone plates, and instruments. It also mentions packaging and sterilization requirements, indicating a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states the device is comprised of bone screws, bone plates, and instruments made of titanium. These are physical implants and tools used within the body.
- Intended Use: The intended use is for "stabilizing and fixating bone grafts, bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity." This is a surgical procedure involving physical manipulation and implantation, not the analysis of bodily specimens.
The device is a surgical implant system used for bone regeneration procedures, not for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
The device is intended for use in stabilizing and fixating bone grafts, bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity. Single patient use only.
Product codes (comma separated list FDA assigned to the subject device)
JEY, DZL
Device Description
The Jeil Bone Fixation System is comprised of bone screws, bone plates and instruments. The bone screws are composed of the titanium alloy (ASTM F136-98) and the bone plates are composed of the pure titanium (ASTM F67 Grade 1). The screws are offered in following range; diameter (1.4 ~ 2.0mm) and length (4.0 ~ 16.0mm). Also, the tip of screw has different 2 types; the self-tapping available type and the type that require the pre-drilling. (Surgeon's option) The bone plate is offered in 0.1mm and 0.2mm thickness and in length 37mm and 24mm. The applied titanium mesh over the cavity provides stable mechanical support while maintaining the sufficient flexibility for placement with decreasing tissue compliance related complication. The applied titanium screw for the on-lay bone above the alveolar bone provides stable mechanical rigidity and stability. This device system and each device are provided non-sterile. Therefore, this device must be sterilized prior to use. Steam sterilization is recommended. This device is provided with kit or Polyethylene package bag. The top of package bag is scaled with sealing strip. This system could be used with various instruments as follows: Screw Block, Screw driver body, Driver shaft, Pilot drill.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K011698, K984230, K033767, K023365, K023360
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
0
MAY 2 6 2005
EXHIBIT 2 Jeil Medical Corporation 808, ACE Techno-Tower, 3rd 197-48, Kuro 3Dong Kuro-Ku. Seoul, KOREA Telephone : 82-2-2109-6781~9 Fax: 82-2-2109-6791 March 7, 2005 Contact: N.K.Kim, R&D Director 510(k) Summary
-
- Identification of the Device: Proprietary-Trade Name: Jeil Bone Fixation System Classification: Class II per regulations 872.4760 Classification Name/Product Codes: JEY Common/Usual Name: Bone Screw, Bone Plate
- Equivalent legally marketed devices: Straumann GBR System (K011698) Osteo-Mesh TM-300 . 2. (K984230), Dual Top Anchor System (K033767), Leforte System Plate (K023360), Leforte System Screw (K023365).
- Indications for Use (intended use). The device is intended for use in stabilizing and fixating bone ra grafts, bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity. Single patient use only
- Description of the Device: The Jeil Bone Fixation System is comprised of bone screws, bone 4. plates and instruments. (Refer the below table) The bone screws are composed of the titanium alloy (ASTM F136-98) and the bone plates are composed of the purc titanium (ASTM F67 Grade 1). The screws are offered in following range; diameter (1.4 ~ 2.0mm) and length (4.0 ~ 16.0mm). Also, the tip of screw has different 2 types; the self-tapping available type and the type that require the pre-drilling. (Surgeon's option) The bone plate is offered in 0.1mm and 0.2mm thickness and in length 37mm and 24mm. The applied titanium mesh over the cavity provides stable mechanical support while maintaining the sufficient flexibility for placement with decreasing tissue compliance related complication. The applied titanium screw for the on-lay bone above the alveolar bone provides stable mechanical rigidity and stability. This device system and each device are provided non-sterile. Therefore, this device must be sterilized prior to use. Steam sterilization is recommended. This device is provided with kit or Polyethylene package bag. The top of package bag is scaled with sealing strip. This system could be used with various instruments as follows.
- Screw Block .
- . Screw driver body
- Driver shaft .
・
- . Pilot drill
- Potential Adverse Affects and Complications: (Common to all devices of this type) 5.
- Poor bone formation, Osteoporosis, Osteomyclitis, inhibited revascularization, or . infection can cause loosening, cracking or fracture of the device or premature loss of fixation with the bone, leading to nonunion.
- Migration, bending, fracture or loosening of the implant. .
- Metal sensitivity, or allergic reaction to a foreign body. .
- Pain, discomfort, or abnormal sensation due to the presence of the device. .
1
- Increased fibrous tissue response around the fracture site and/or the implant. .
- Necrosis of bone.
- . Inadequate healing.
Apart from these adverse effects there are always possible complications of any surgical procedure such as, but not limited to, infection, nerve damage, and pain which may not be related to the implant
Safety and Effectiveness, comparisons to predicate devices:
| Device Name | Straumann
GBR System | Osteo-Mesh
TM-300 | Dual Top
Anchor System | Le forte System
Screws | Le forte System
Plates | Jeil Bone
Fixation
System |
|---------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | Straumann USA | Osteogenics
Biomedical, Inc | Jeil Medical
Corp. | Jeil Medical
Corp. | Jeil Medical
Corp | Jeil Medical
Corp. |
| 510(K) Number | K011698 | K984230 | K033767 | K023365 | K023360 | |
| Material | Pure Titanium
(ASTM F 67 Gr
1/4) | Pure Titanium
(ASTM F67) | Titanium Alloy
(ASTM F 136-
98) | Titanium Alloy
(ASTM F 136-
98) | Pure Titanium
(ASTM F67 Gr
-
| Titanium Alloy
(ASTM F 136)
Pure Titanium
(ASTM F 67 Gr
-
|
| Intended use | Use in
stabilizing and
fixating bone
grafts, bone
filling material,
and/or barrier
membranes
used for
regeneration of
bone in the oral
cavity.
For the
placement of
dental implants
in previously
unsuitable sites. | For stabilization
and
support of bone
grafts in dento-
alveolar bony
defect sites | use as a bone
screw in
temporary
fixation of the
maxilla and
mandible,
providing
indirect
stabilization of
orthodontic
treatment of the
maxilla and/or
the mandible | Fracture fixation
as well as
reconstruction
and stabilization
of small (i.e.
toe, foot, finger,
hand, etc) and
the
mandibulofacial
(i.e. mandible
and maxilla)
bones | Used for
internal fracture
fixation of small
bone(toe, finger
etc and
reconstruction
of mandible &
maxillar
(Craniomaxillofa
cial skeleton) | Use in
stabilizing and
fixating bone
grafts, bone
filling material
and/or barrier
membranes
used for
guided
bone/tissue
regeneration in
the oral cavity |
| Single use | Yes | Yes | YES | YES | YES | YES |
| Sterile | Non-Sterile
(Sterilize before
use) | No comment | Non-Sterile
(Sterilize before
use) | Non-Sterile
(Sterilize before
use) | Non-Sterile
(Sterilize before
use) | Non-Sterile
(Sterilize
before use) |
-
- Conclusion: In all respects, the Jeil Bone Fixation system components are the equivalent of currently marked devices. They are made of the same materials and have similar dimensions and characteristics. Potential adverse effects are identical to those of predicate devices. These devices are manufactured from titanium alloys that are used generally in this kind of bone screw and bone plate in devices that are manufactured and sold around the world. This device is substantially equivalent in design, material, intended use and function to the products on the table above.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of a human figure with three arms or lines extending from the head, resembling a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 6 2005
Jeil Medical Corporation C/O Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015
Re: K050669
Trade/Device Name: Jeil Bone Fixation System (various models) Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY, DZL Dated: March 7, 2005 Received: March 15, 2005
Dear Mr. Kamm:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Kamm
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Syrie Michael MD.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K050669 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Device Name: Jeil Bone Fixation System
Indications For Use: The device is intended for use in stabilizing and fixating bone grafts, bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity. Single patient use only.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Super Runner
(Division Sign-Off) (Division Sign-on)
Division of Anesthesiology, General Hospital, Infection Control. Dental Devices
510(k) Number: KO 50664
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